Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 3

Conditions: Ischaemia-reperfusion Injury

Treatments: Drug: Diltiazem; Drug: diltiazem and acetylcystein; Drug: Placebo; Drug: Acetylcystein

Study type: Interventional

Funder types: Other

Identifiers

NCT01771978

2276

Details and patient eligibility

About

Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age included between 60 and 80 years

Exclusion criteria

• Age < 60 or > 80 years
• Pregnancy
• The allergy in used medicines (N-acétylcystéine, Diltiazem)
• Presence of a pathology valvulaire associated
• Urgency
• Unstable angor
• Bypass as a matter of urgency
• Recours peropératoire to a CEC
• FE < 0,40
• BAV of the 2nd and 3rd not sailed degree
• fibrillation or flutter little finger.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups, including a placebo group

Arm1: control group

Placebo Comparator group

Description:

Received 250 ml of a 5% dextrose solution as placebo drug

Treatment:

Drug: Placebo

Arm 2: diltiazem group

Experimental group

Description:

Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution

Treatment:

Drug: Diltiazem

Arm 3: acetylcystein group

Experimental group

Description:

Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution

Treatment:

Drug: Acetylcystein

Arm 4: diltiazem and acetylcystein group

Experimental group

Description:

Received a combination of drug : bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution and 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution

Treatment:

Drug: diltiazem and acetylcystein